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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004597-28 | EudraCT Number |
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This single-center, open-label study will assess the excretion balance, pharmacokinetics and metabolism of oral [14C]-labeled RO4917523 in healthy male volunteers. Subjects will receive a single oral dose of [14C]-labeled RO4917523 and an intravenous tracer dose of [13C]-labeled RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time on study is up to 15 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-labeled RO4917523 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO4917523 | Drug | [14C]-labeled RO4917523, single oral dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Elimination: urinary and fecal recovery of total radioactivity | Pre-dose and up to approximately Day 18 post-dose | |
| Plasma concentrations of RO4917523 | Pre-dose and up to approximately Day 18 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolites of RO4917523 in plasma/urine/blood pellet/feces based on radioactive metabolic profiling | Pre-dose and up to approximately Day 18 post-dose | |
| Absolute bioavailability: Area under the concentration-time curve (AUC) | Pre-dose and up to approximately Day 18 post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuidlaren | 9471 GP | Netherlands |
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| ID | Term |
|---|---|
| C000596770 | 2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine |
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| RO4917523 |
| Drug |
[13C]-labeled RO4917523, single intravenous tracer dose |
|